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    Vonjo™

    Drug - Vonjo™ (pacritinib) [CTI BioPharma Corp.]

    October 2022

    Therapeutic area - Oncology, Oral - Hematologic

    Initial approval criteria

    • Patient is at least 18 years of age AND
    • Patient has a confirmed diagnosis of intermediate-1 or -2 or high risk myelofibrosis (MF) (including primary, post-polycythemia vera, or post-essential thrombocythemia MF) AND
    • Patient has a baseline platelet count of < 50 x 109/L within the previous 30 days AND
    • Patient has splenomegaly (e.g., ≥ 5 cm below costal margin) on physical or radiological examination AND
    • Therapy will NOT be used in combination with another JAK2-inhibitor type drug (e.g., ruxolitinib, fedratinib) AND
    • Patient does NOT have an active bleed AND
    • Patient has adequate renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min AND
    • Patient does NOT have moderate or severe hepatic impairment (Child-Pugh B or C) AND
    • Patient has a baseline QTc of ≤ 480 msec AND
    • Patient will avoid concomitant therapy with all of the following:
      • Coadministration with strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, nefazodone) AND
      • Coadministration with moderate CYP3A4 inhibitors (e.g., aprepitant, ciprofloxacin, clindamycin), or if therapy is unavoidable, the patient will be monitored closely for adverse reactions and/or dose modifications will be implemented AND
      • Coadministration with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort, phenytoin) AND
      • Coadministration with moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil), or if therapy is unavoidable, the patient will be monitored closely for loss of efficacy and/or dose modifications will be implemented AND
      • Coadministration with drugs that prolong QT/QTc interval (e.g., amiodarone, sotalol, levofloxacin, venlafaxine, quetiapine, sumatriptan)
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Patient has documented treatment response with a decrease in spleen size OR improvements in other myelofibrosis symptoms (e.g., fatigue, bone pain, frequent infections, fever, night sweats, easy bruising/bleeding) AND
    • Patient has NOT experienced any treatment-restricting adverse effects (e.g., serious or life-threatening hemorrhage, severe diarrhea, clinically significant worsening of thrombocytopenia, QTc prolongation > 500 msec or > 60 msec from baseline, major adverse cardiac events [MACE], thrombosis, secondary malignancies, serious infections)
    • Renewal approval is for 6 months

    Quantity limits

    • 136 capsules per 34 days

    Background

    Vonjo is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Questions?

    MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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